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PDA Technical Reports List - Product Catalog - Parenteral ...

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PDA Technical Reports List - Product Catalog - Parenteral ...

PDA Technical Reports No. TITLE Paper Version Digital Version 1 ... 20 Report on Survey of Current Industry Gowning Practices 1990 01020 41239 21 Bioburden Recovery Validation 1990 01021 41258 ... 25 Blend Uniformity Analysis: ...

https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf

Date added: October 8, 2012 - Views: 521

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Technical Report No. 15 Revised 2009 Validation of Tangential ...

2 © 2009 Parenteral Drug Association, Inc. Technical Report No. 15 1.0 Introduction Technical Report No. 15: Industrial Perspective on Validation of Tangential Flow Filtration in Biopharmaceutical

http://store.pda.org/tableofcontents/tr1509_toc.pdf

Date added: January 14, 2013 - Views: 52

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PDA Draft Technical Report No. 29 - Pharmanet

PDA Technical Report No. 29 Points to Consider for Cleaning Validation DRAFT March 30, 1998 ... 25 Swabs and Wipes ..... 25 Rinse Sampling ... PDA Draft Technical Report No. 29 Author: MADSEN

http://www.pharmanet.com.br/pdf/tr29-002.pdf

Date added: April 30, 2012 - Views: 367

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THE USE OF STRATIFIED SAMPLING OF BLEND AND DOSAGE UNITS TO ...

statistical analysis such as the use of methods described in PDA Technical Report 254 should be applied to assess the situation. ... Technical Report No. 25, Blend Uniformity ... The stratified sampling criteria defined in this document are acceptable for

http://www.pqri.org/pdfs/DTC/Articles/Final_BUWG_Stratfied_Sampling.pdf

Date added: April 11, 2012 - Views: 26

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Technical Report No. 48 Moist Heat Sterilizer Systems: Design ...

Technical Report No. 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation ... • PDA Technical Report No. 1, Revised 2007, (TR 1) ... 25 Sterilizer Design • Cycle time and throughput

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-48-moist-heat-sterilizer-systems.pdf?sfvrsn=6

Date added: July 31, 2014 - Views: 2

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TECHNICAL REPORT NO . 36 - SDFS Arizona Data Services Program

TECHNICAL REPORT NO. 36 MAMMALS OF THE QUITOBAQUITO MANAGEMENT AREA, ORGAN PIPE CACTUS NATIONAL MONUMENT, ARIZONA by Yar Petryszyn and E. Lendell Cockrum ... 25 . iv FIGURES AND TABLES FIGURES Figure 1. The Quitobaquito Management Area, Organ

http://sdfsnet.srnr.arizona.edu/data/techreports/TECHRPT36.pdf

Date added: October 8, 2012 - Views: 26

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Cleaning Verification / Validation of Pharmaceutical ...

PDA Technical Report No. 29, Revised 2012: ... Bioburden NMT 25 cfu per 25 cm2 – This level is readily dealt with by typical SIP processes. ... • The work of the PDA Technical Committees and National Regulatory Authorities . Discussion.

http://www.aaps.org/uploadedFiles/Content/Sections_and_Groups/Regional_Discussion_Groups/Southern_California_Pharmaceutical/Announcements/SC%20PDG%20Cleaning%20Verification%2019%20SEP%202013.pdf

Date added: October 30, 2013 - Views: 18

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PDA: A Global Cleaning Validation Association

1998: PDA Technical Report No.29 «Points to consider for Cleaning Validation» ... The result is multiplied by surface to be samples (tipically 25-100 cm2) Rinse Limit: is obtained dividing the MAC value by the total volume used to rinse

http://www.pda.org/docs/default-source/attendee-presentations/europe/2014/2014-pda-conference-on-trends-in-aseptic-manufacturing/giovanni-vitali---ctp.pdf?sfvrsn=7

Date added: September 12, 2014 - Views: 1

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PDA TECH REPORT #33 - HubSpot

PDA TECHNICAL REPORT NO.33 EVALUATION, VALIDATION AND IMPLEMENTATION OF NEW MICROBIOLOGICAL TESTING METHODS Table of Contents Part One: Selection of New Microbiological Methods

http://cdn2.hubspot.net/hub/54227/file-14538112-pdf/docs/tr33.pdf

Date added: November 22, 2013 - Views: 21

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AS A MEMBER, YOU’LL SAVE! New Release at the PDA Bookstore

Pharmaceutical Cold-Chain Interest Group and co-author of PDA Technical Report No. 39. go.pda.org/CCCN www.pda.org/bookstore | Tel: +1 (301) 656-5900 | Fax: +1 (301) 986-1361. ... 25 Park Place, Atlanta, GA 30303, U.S.A. PDA Account No. 209364254 | Routing number: ABA# 061000104 | Swift ...

https://europe.pda.org/userfiles/downloads/ColdChain-flyer_orderform.pdf

Date added: October 20, 2014 - Views: 1

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CIP Cycle Development and Cleaning Validation - ISPE

PDA Technical Report #49 - Points to Consider ... Biotechnology Perspective, PDA, 1996 – Validation study design and acceptance criteria . Cleaning Validation ... (2.5 hr - 2.0hr) / cycle = 25 hrs / month = 275 hr / year

http://www.ispe.org/great-lakes/2012cleaningvalidation.pdf

Date added: September 12, 2012 - Views: 133

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Bioburden Biofilm Management Technical Report Update

PDA Technical Report on Bioburden and Biofilm ... develop visible colonies on R2A medium at 25 to 30oC ...

http://www.a.pda.org/docs/default-source/attendee-presentations/north-america/2014/2014-pda-annual-meeting/kalavati-suvarna-phd.pdf?sfvrsn=5

Date added: September 1, 2014 - Views: 3

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Qualification of temperature-controlled storage areas

2.6.1 Checking installed systems, sub-systems and components ..... 25 2.6.2 Temperature mapping – full ... 5 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products:

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-qualification-storage-areas-final-sign-off-a.pdf

Date added: June 5, 2014 - Views: 4

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Monitoring isolator air - 800ezmicro - Microbiology International

As a PDA technical report states: “An isolator is sealed or is ... for isolators: No interference with the normal usage of ... USP 25, Chapter 1116, Microbical Evaluation of Cleanrooms and other Controlled Environments, 2002. 4.

http://www.800ezmicro.com/component/docman/doc_download/266-monitoring-isolator-air.html

Date added: October 24, 2012 - Views: 28

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USP Controlled Room Temperature Range Expansion

revision—as yet unproposed in PF—of USP's definition for Controlled Room Temperature from 20°–25° to 2°–30°. BACKGROUND . The design of stability studies during pharmaceutical product development and ... (see PDA Technical Report 53). 4.

http://www.thermosafe.com/blog/wp-content/uploads/2014/02/S20102.pdf

Date added: June 3, 2014 - Views: 3

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A New Vision - bioMerieux | In Vitro Diagnostics ...

Media Fill Test (MFT) ... PDA Technical Report No. 36, Current Practices in the Validation of Aseptic Processing – 2001. ... after 8 days of incubation at 20-25°C on culture media from different suppliers. After 8 days at 20-25°C, ...

http://www.biomerieux-usa.com/upload/Media%20Fill%20Brochure-1.pdf

Date added: October 28, 2012 - Views: 12

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Libero. New dimensions. The independent PDF Data Logger.

... conform with PDA Technical Report No 39 ... Libero Sample Analysis Report . elproLibero Synergy between Datalogger & Adobe® PDF/A Seite 4 von 12 Libero Display – Explanations: Bat.End ... 25 to 40°C 2 days 8 to 25°C 6 days

http://www.nordealer.com/pdf-032008/Libero%20spec.%20tecniche.pdf

Date added: October 4, 2011 - Views: 7

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Temperature mapping of storage areas - World Health Organization

1 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products: ... temperature range (e.g. hot spots identified between +23°C to +25°C in a room with a specified temperature range +15°C to +25°C). Technical Supplement: ...

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf

Date added: June 8, 2014 - Views: 4

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In this issue: p~LAL UPDATE® - Associates of Cape Cod, Inc.

Depyrogenation, PDA Technical Report No.3, PDA, Philadelphia, PA). Three parametersappropriatedfrom the theory of sterilization that are frequently encountered in the discussions of depyrogenation are D value. z value and Fvalue. ... 25 0.5 1.5 Time [hr]

http://www.acciusa.com/pdfs/newsletter/LAL_Vol.11No.5.pdf

Date added: March 14, 2012 - Views: 10

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Addendum No. 1 to ON-CALL PDA TECHNICAL AND STAFFING ASSISTANCE

February 25, 2014 . Addendum No. 1 . to . REQUEST FOR QUALIFICATIONS . ... This letter is Addendum No. 1 to the Request for Qualifications for On-Call PDA Technical And Staffing Assistance dated January 28, 2014 (“RFQ”). Where text is revised, deleted text is shown in strike-through format ...

http://bids.mtc.ca.gov/download/687

Date added: March 17, 2014 - Views: 1

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2 Manuscript Title - ECVS INC

13 This article describes a method for achieving the load equivalence model described in PDA Technical 14 Report 1 (TR1), ... 25 minimizing time and qualification requirements for new equipment qualification for similar loads/use,

http://ecvs-inc.com/Library/Risk%20Based%20Approach%20to%20Variable%20Load%20Configuration%20Validation%20in%20Steam%20Sterilization_Final%20Manuscript%20for%20PDA.pdf

Date added: June 7, 2012 - Views: 17

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SporeNews MesaLabs - Mesa Labs Biological Indicators

Section 8.1 of PDA Technical Report No. 51 suggests that re-running the cycle with a different lot of BIs or re-running the cycle with duplicate or triplicate BIs in the same location may be necessary.3 ... 25, 101-121. Created Date:

http://biologicalindicators.mesalabs.com/wp-content/uploads/sites/31/2014/03/Spore-News-Vol-9-No4.pdf

Date added: August 4, 2014 - Views: 1

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Libero. The Overview of the Models. - Bancolini

Features / Models Libero Ti1 Libero Ti1-S Libero Ti1-L Libero Te1-N ... • +/- 0.2°C in the range of -10° to 25°C ... conform with PDA Technical Report No 39 Start-Up Delay 0 minutes to 1 day Battery (built-in) Life time

http://www.bancolini.com/interne/brochure/LIBERO_TechSpecs_en.pdf

Date added: May 13, 2013 - Views: 2

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The Parenteral Drug Association presents 2013 PDA Europe ...

special group rate until 25 January 2013, Code: PDA. Reservation link: Marriott Hotel Housing at the selected hotel will be in high demand, ... 11:30 About RMM Validation/Technical Report No. 33 Michael Miller, Microbiology Consultants 12:00 Q & A, Discussion

http://www.tiselab.com/pdf/2013_Microbio_Brochure.pdf

Date added: November 13, 2013 - Views: 12

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Case Study: Computer Supplier Evaluation Practices of the ...

5.3 Other Lessons.....25 6 Conclusion ... Audit Audit performed in accordance with PDA Technical Report No. 32 and brokered by ARC for participating suppliers or supplied by

http://www.sei.cmu.edu/reports/03tr011.pdf

Date added: January 31, 2012 - Views: 14

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Design of Experiments to Establish Temperature and Humidity ...

to Establish Temperature and Humidity Limits for Temperature Excursions ... •PDA Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products: ... and the shelf life at 25 °C at 60 %RH must be

http://www.mbswonline.com/upload/presentation_5-24-2011-19-20-3.pdf

Date added: October 17, 2012 - Views: 6

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Report # MATC-UI: 117 Final Report - Mid-America ...

Performing Organization Report No. 25 -1121 0003 117 9. ... The challenges that face autonomous vehicle are still significant. ... PDA personal digital assistant PRT personal rapid transit RSU road-side units RUC road use charging

http://matc.unl.edu/assets/documents/matcfinal/Schwarz_TowardsAutonomousVehicles.pdf

Date added: February 15, 2014 - Views: 2

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PDA Letter • February 2007 Science & Technology Articles of ...

PDA Letter • February 2007 9 Science & Technology Bacterial Adhesion to Surfaces: ... preservatives tested were 0.25% ... PDA Technical Report # 28 (Revised) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals.

http://www.microbiol.org/wp-content/uploads/2010/07/sutton.pda_letter.0702.pdf

Date added: March 9, 2012 - Views: 11

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LIBERO PDF Logger Benefits A most cost efficient solution!

Libero. Cold Chain Monitoring: No software at destination ... and 25 °C to 70 °C • Resolution: 1/10 °C ... minute or more, programmable • Programmable temperature alarms: a) 2 limits or b) 5 multiple alarm ranges, conform wit PDA Technical Report No 39 (Cold Chain Guidance for Medical ...

http://nordealer.com/pdf/elpro_libero_folder_generale.pdf

Date added: May 13, 2013 - Views: 5

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Autoclaves Qualification & Validation - Надлежащая ...

PDA Technical Reports • PDA Technical Report No. 1, ... 25 of 39 Autoclaves: Qualification & Validation Holger Fabritz ... prolonged sterilisation run of empty autoclave after runs with bio-indicators) - PQ / PV - 31 of 39 Autoclaves: ...

http://www.gmpua.com/Equipment/Sterility/Sterilization/QualificationofAutoclaves.pdf

Date added: October 19, 2011 - Views: 143

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Parametric Release October 22, 2010 - Abrasp

Essential Elements of a Parametric Release Program: PDA Technical Report 30 ... PDA Technical Report No. 30 (2010 Revision) Title: Parametric Release of Pharmaceutical ... 25 Raw Material, In-Process and Pre-

http://www.abrasp.org.br/Downloads/2010/BrazilPR.pdf

Date added: May 10, 2012 - Views: 7

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PMF NEWSLETTER - The Microbiology Network | Dedicated to the ...

taminated (PDA Technical Report No. 51). The bio-logical indicators used can be readily enumerated. The micro-organism used must be appropriate, that is ... has nearly 25 years of experience in the GMP industry, in-cluding Quality Control Microbiology, Quality Assurance

http://www.microbiologyforum.org/content/file/PMFNews.17.05.1105.pdf

Date added: December 8, 2013 - Views: 1

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PDA Forensic Tools - NIST Computer Security Division ...

PDA Forensic Tools: An Overview and Analysis Rick A yers Wayne Jansen . ii ... and technical analysis to advance the development and ... etc.), a timeline, and the generated report from the script. 25. Graphics Library After a script to find all examiner specified types of graphics files has ...

http://csrc.nist.gov/publications/nistir/nistir-7100-PDAForensics.pdf

Date added: February 14, 2012 - Views: 40

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Dissertation Version 2-4 - fu-berlin.de

Seite 157 von 160 Literaturverzeichnis Kürzel Verweis [PDA TR No.30] PDA Technical Report N0. 30: Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat, PDA

http://www.diss.fu-berlin.de/diss/servlets/MCRFileNodeServlet/FUDISS_derivate_000000001707/10_Teil11.pdf?hosts=

Date added: February 28, 2012 - Views: 23

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Technical Report 47 – “Creating a Research Database on ...

... TECHNICAL REPORT NO. 471 By Elizabeth A. Ruff, M.S./Ed.S. Robert C. Reardon, ... technical reports, and supplemental products such as dissertations. ... Technical Report 47 –25 Thoughts Inventory (Sampson, Peterson, Lenz, Reardon, & Saunders, ...

http://career.fsu.edu/documents/technical%20reports/Technical%20Report%2047/TR47.pdf

Date added: October 30, 2011 - Views: 48

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Development and validation of a microbial counting method for ...

counting was performed according to the USP 30 and PDA Technical Report No. 33. The method used ATCC Gram positive and Gram negative microorganisms, yeasts, ... This compendium allows for up to 25% variation in microbial recovery for inoculations of test organisms at

http://www.scielo.br/pdf/bjps/v47n3/13.pdf

Date added: November 27, 2012 - Views: 7

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Training to Excellence - Nanyang Polytechnic

and SIP processes such as those in PDA Technical Report No. 26, examples of stepthrough simulations of proper SIP processes of common system designs will be examined.. ... 25 May 2014 / 18 August 2014 DATE: 29 - 30 April 2014 LOCATION: Pall Singapore, Centre of Excellence.

http://www.nyp.edu.sg/pdc/display_file.cfm?file_name=NYP+-+Pall+Training+Brochure+2014.pdf&ff=Y

Date added: April 6, 2014 - Views: 6

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LIBERO: Innovation Leader in Cold Chain Monitoring

- Temperature accuracy of ± 0.2°C between -10°C..+25°C - 5 alarm / time zones - Simple Bracket - Alarm Bracket - Connectors for external probes Accessories. 5 ... to PDA Technical Report No 39 -Validation certificate-IQ/OQ documentation is made available IT Manager: Reliability and seamless

http://www.elpro.com/uploads/tx_elproindustries/LIBERO_Innovation_Leader.pdf

Date added: February 5, 2014 - Views: 1

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Event Guide - IBC Life Sciences - Your Connection to the Life ...

February 25 - March 1, 2013 Hyatt Regency Huntington Beach Resort & Spa Huntington Beach, CA. ... PDA Technical Report No. 50: Application of Non-Culture Testing Methodology for the Detection of Mycoplasma Barbara J. Potts, Ph.D., Senior Consultant,

http://www.ibclifesciences.com/upload/wysiwyg/biopharma_series/B13155/B13155guide.pdf

Date added: October 15, 2013 - Views: 4

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Auxilium's QC micro automation - Lonza

Lonza / 25 October 2011 . slide 2 Today’s Presenters ... PDA Technical Report No. 31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems ...

http://bio.lonza.com/uploads/tx_mwaxmarketingmaterial/Lonza_Webinars_Auxiliums_QC_micro_automation_using_MODA_solution.pdf

Date added: May 4, 2013 - Views: 3

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Terminal Sterilization vs. Aseptic Processing

PDA Technical Report #36 : Current Practices in the Validation of Aseptic Processing ... minimum dose of ≥25 KGy ? Can the formulation be filtered through ... Steam sterilization of terminal sterilization the reference

http://forums.pharmacyonesource.com/phos/attachments/phos/pharmacy_ops/1377/1/terminal%20sterilization%20v%20aseptic.pdf

Date added: June 4, 2012 - Views: 95

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/tardir/tiffs/a416880 - DTIC

the company had needed 25 people at each of its manufacturing sites. ... Audit performed in accordance with PDA Technical Report No. 32 and brokered by ARC for participating suppliers or supplied by subscribers as required by their level of subscription

http://www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA416880

Date added: November 29, 2013 - Views: 5

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PROFESSIONAL SERVICES AGREEMENT between METROPOLITAN ...

MTC/Consultant PDA Technical And Staffing Assistance Page 2 In the performance of its services, CONSULTANT represents that it has and will exercise

http://bids.mtc.ca.gov/download/680

Date added: February 12, 2014 - Views: 4

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Cleaning Validation with TOC - Insatech

Cleaning Validation with TOC • Jamie Thompson, ... Refer to PDA Technical Report 29 and 49 for further guidance 2. Key points: Safety factor depends on route of administration, different limits possible for ... INSA 25 / 14 Summary

http://www.insatech.com/downloads/Cleaning_Validation_Jamie_Thompson_GE_Power___Water.pdf

Date added: April 1, 2014 - Views: 2

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A Consensus Rating Method for Small Virus-Retentive Filters ...

final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration. KEYWORDS: Virus retentive filtration, Virus safety, Bioprocessing ... absolute for 20-nm to 25-nm viruses and that non-absolute filters are known to show a range of particle or ...

http://www.mrzgroup.umd.edu/pdfs/2008_PDA_virus.pdf

Date added: April 3, 2014 - Views: 1

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Human Factors Guidance for the Use of Handheld Portable and ...

Technical Report This document is available to the public through the National ... This report provides human factors guidance for the selection and use of handheld, portable, ... PDA Personal Data Assistant .

http://hf.tc.faa.gov/technotes/dot_faa_ct_05_15.pdf

Date added: February 12, 2012 - Views: 14

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Oregon Research Institute

Oregon Research Institute The Eugene-Springfield Community Sample: Information Available from the Research Participants Lewis R. Goldberg ORI TECHNICAL REPORT Vol. 48 No. 1 March 2008 . 1 ... (25) Experimental Personality Survey (EPS), ...

http://projects.ori.org/lrg/PDFs_papers/ORI_TechnicalReport_ESCS_Mar08.pdf

Date added: May 3, 2013 - Views: 15

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Review Article

(WHO) Technical Report Series, No. 953, ... – PDA Technical report 46, 2009 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User (10) ... of the product is endangered by this temperature excursion.

http://xa.yimg.com/kq/groups/2299115/51192317/name/Stability%20Studies%20Biotech%20prod.pdf

Date added: October 7, 2012 - Views: 3

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Supplier Assessments Audits - İKEV

PDA Technical Report 32 1. Quality System 2. Project Management 3. Methodology 4. Testing 5. Configuration Management 6. Manufacturing 7. Documentation and ... Computerized Systems Validation Supplier Assessment 25 Dr. Guenter Generlich After the Audit

http://www.ikev.org/haber/2003valid/10%20Supplier%20Audits.pdf

Date added: March 25, 2012 - Views: 91

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20030329-01A Pharma and Life Sciences - Надлежащая ...

Particle Counting and Environmental Monitoring In Pharmaceutical / Life Sciences. www.golighthouse.com ... H NS 35000 200 0 NS 25 15 10 ... PDA Technical Report No. 13 Fundamentals of a

http://www.gmpua.com/CleanRoom/Monitoring/PharmLifeSciences.pdf

Date added: January 3, 2012 - Views: 35